Clinical Study to Collect Clinical Data Sets for Development of Insulin Glargine Titration Algorithms - Delta Study

ikfe GmbH0 个研究点开始时间: 2012年1月3日最近更新: 2012年10月16日

适应症

试验速览

暂无简介。

•1.Type 2 diabetes mellitus
•2.Improvement of an existing BOT with Insulin Glargine + OAD or Insulin Glargine alone
•3.HbA1c between 6.5% and 9.5% inclusively
•4.Age between 30 and 75 years inclusively
•5.Body mass index =40 kg/m2
•6.Patient consents that his/her family physician will be informed of trial participation
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1.Type 1 diabetes mellitus
•2.Instable OAD therapy during the last 6 weeks prior to the study
•3.Severe retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases
•4.Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study
•5.Subject without legal capacity
•6.Pregnant or lactating women
•7.History of drug or alcohol abuse within the last five years prior to screening
•8.Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
•9.History of severe or multiple allergies
•10.Treatment with any other investigational drug within 3 months prior to screening
•11.Progressive fatal disease
•12.Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner

发起方

ikfe GmbH